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Access to Drugs & Diagnostics: A Field Reality Survey

Detailed survey on drug access & availability of diagnostics for HIV patients in different regions.

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Access to Drugs & Diagnostics: A Field Reality Survey

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  1. What is the reality in the field?Survey of access to drugs and diagnostics ImanWanis and Philippa Easterbrook World Health Organization, HIV Department (ATC) Geneva, Switzerland July 2011

  2. Survey methodology • 19 persons from Asia, Africa • Most seeing >100 patients/year • Semi-structured telephone interview • Uganda (4 physicians, and 1 lab manager) • Malawi (2 physicians) • Botswana (1 physician) • Laos (1 MOH) • Vietnam (1 physician) • South Africa (3 physicians, and 1 microbiologist) • Ethiopia (1 pharmacist) • Cambodia (1 physician MSF) • Thailand (1 physician) • India (1 physician) • CIPLA CEO

  3. Perspectives on epidemiology/burden • No of cases per year • Pietermaritzburg: 60-80 • Kampala: 750 • Malawi: 2000 • Laos: 100 (25 at 4 sites) • Declining incidence (Thailand, Botswana, South Africa- slight) • Seasonal peak in rainy season (Uganda) • IRIS • 30-50% unmasking (S. Africa and Uganda) • 30% (Thailand) • 75% pre-ART; <5% unmasking (Malawi)

  4. Mortality Trends in Treatment of Adults with Incident Cryptococcosis, South Africa, 2005-2008 • Reasons for persistent high fatality: • Late presentation with advanced HIV and advanced CM/ severe neurological impairment • In South Africa (2005-8), 81% of 3132 patients had CD4 <100 cells/ml (Govender et al, CROI 2010) • 2. Amphotericin B toxicity (COAT trial) Impact of introduction of routine K+ supplementation : COAT Trial, Uganda Source: Govender et al, CROI 2010 Source: Bahr et al 2011, ICCC 2011 Case fatality rates remain high despite increasing access to Amphotericin B

  5. Diagnostics • Different diagnostic approaches, esp. in SSA • CSF India ink only • CSF India ink and CRAG simultaneously • CSF CRAG only on India Ink negative (S. Africa, Botswana) • Culture only in few sites • Significant variation in approach to CRAG funding • Global Fund (Laos), PEPFAR, NGOs (MSF) (Malawi), government only if preceeding HIV +ve diagnosis (Uganda) • Screening not seen as high priority • Thailand has now introduced • Botswana under discussion • Wide variation in access to CRAG esp. in SSA (India ink in 75% of labs, ACP 2007) • Only in main city hospitals or private sector • Research studies

  6. Amphotericin B • Wide variation in access to amphotericin B, esp. in SSA • Generally main city hospitals only • Drug stock-outs a problem • Poor forecasting, and distribution • International shortage at present • Wide variation in availability of generic amphotericin B • 4 generic companies in India • Few or none in SSA • 90% reduction in price of liposomal ampho negotiated (MSF/WHO) for treatment of visceral leishmaniasis • Significant variation in approaches to funding of amphotericin B • Global Fund (Laos) • PEPFAR (selected sites in Uganda) • NGOs (MSF) • National government (Asia, Botswana, South Africa) • UNITAID donation • Self-pay (less than half of patients can afford in Uganda)

  7. Fluconazole • Perception that associated with higher mortality • Free through Pfizer donation • Increasingly used as first line in absence of amphotericin B • Higher doses starting to be used; no problems reported • Malawi: 800mg 2w then 600mg • Uganda: 1200mg for 2 w then 400mg 8w • Often fluconazole not available, even in cities – no clear reason

  8. Flucytosine • No registration or availability in any SSA, despite inclusion in several national guidelines • Limited number of manufacturers • Very high cost $3.22 per tablet, about $ 32.22 per day

  9. Monitoring • Wide variation in monitoring practice and funding source for tests e.g. Uganda self-pay • No monitoring of ICP; manometers rarely available • Very limited toxicity monitoring (Malawi) • SOPs (Botswana) • K+, creat., CBC (Day 1, 7 and 14) (Laos) • Baseline Hb and after 7 days, Electrolytes and LFTs after 4 days (Uganda), or every 2-3 days • Wide variation in funding source for tests • Uganda self-pay • National government (Laos, South Africa) • Delays in receiving results • Use of pre-emptive fluid load and K replacement only in few settings

  10. What they would like to see? 1 • Free/low cost diagnosis, Rx and monitoring • Ready access to rapid low cost diagnostics (in serum and CSF) to allow earlier diagnosis • Good drugs given late will not impact on prognosis • Enthusiasm for LFA • Screening not yet indicated • Simplified treatment and need for cost-effectiveness comparisons that factor in monitoring and toxicity management • Short course ampho without need for blood test monitoring • High dose oral fluconazole vs. ampho • Addition of 5FC to fluconazole to reduce risk of relapse (no 5FC in SSA)

  11. What they would like to see 2 • Better treatment access • Several Amb generics in Asia, but not in SSA • No access to 5FC in SSA and costly • PSM needs improvement • Improved referral pathways of Crypto patients for ART • Need for guidance on management of non-responders and late relapses • Need to analyse data from Diflucam partnership – wealth of data

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